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Toxicity Evaluation of a VLP-Based Vaccine Аgainst Human Rotavirus Infection Following a Single Administration in Rats: Serum Biochemistry and Histopathological Examination of Organs and Injection Siteстатья
- Авторы: Ledenev Oleg V., Filatov Ilya E., Eliseeva Olesya V., Latyshev Oleg E., Dyachenko Igor A., Slashcheva Gulsara A., Shaykhutdinova Elvira R., Kazakova Ekaterina N., Sadovnikova Elena S., Patsap Olga I., Lebedeva Varvara V., Murashev Arkady N., Grebennikova Tatiana V.
- Журнал: Journal of Drug Delivery and Therapeutics (JDDT)
- Том: 15
- Номер: 8
- Год издания: 2025
- Издательство: SRG Hospital & Medical College Jhalawar
- Местоположение издательства: India
- Первая страница: 69
- Последняя страница: 79
- DOI: 10.22270/jddt.v15i8.7314
- Аннотация: Virus-like particle (VLP) - based vaccines exhibit outstanding clinical, epidemiological, and immunological efficacy and specificity. The novel technology used for producing their active component without incorporating live viruses enables both injectable and non-injectable (e.g., intranasal) administration, emphasizing the need for a comprehensive safety assessment. This study is part of a preclinical toxicological evaluation program aimed at assessing the safety profile of the “Gam-VLP-rota” vaccine candidate targeting human rotavirus infection. The goal of this extended toxicology study was to confirm the safety of a single intramuscular administration of the vaccine in Sprague-Dawley rats. The study focused on identifying possible adverse effects both acutely (within 24 hours post-administration) and after a 14-day recovery period, aiming to detect delayed toxicological signs. Toxicological endpoints included evaluation of target organs, coagulation parameters, hematology, clinical biochemistry, necropsy findings, and histopathological analysis. This article presents a segment of the results, including changes in serum biochemical parameters after a single immunization and histological examination of internal organs and the injection site in rats.
- Добавил в систему: Леденев Олег Владимирович